Milan, Italy (Press Release) – MolMed S.p.A. (MLM.MI) and Genenta Science (Genenta) signed an agree­ment on a multi-year cooperation to develop and manu­fac­ture a gene ther­apy prod­uct for the treat­ment of multiple myeloma.

In accordance to this agree­ment, MolMed will develop and val­i­date the manu­fac­tur­ing and analytical methods of the Genenta prod­uct that constitute part of the preparatory activities to enter in the clin­i­cal trials. Further­more, MolMed will sup­port Genenta to file the appli­ca­tion dossier required for the authori­sa­tion to proceed with trials.

The agree­ment extends the col­lab­o­ration by ensuring MolMed exclusive prod­uct manu­fac­tur­ing for the clin­i­cal trials, in which the gene ther­apy for multiple myeloma will be in­ves­ti­gated.

"We are pleased to be able to follow up so soon on the devel­op­ment ex­pec­ta­tions antic­i­pated in our recent press release on the approval of 2015 results: this new col­lab­o­ration agree­ment signed with an industrial partner once again con­firms our Company’s excellence in devel­op­ing and manu­fac­tur­ing cell and gene ther­a­pies.” Riccardo Palmisano, MolMed’s CEO commented, “We are confident that the part­ner­ship signed today with Genenta will be both fruitful and successful. A further reason for our satisfaction lies in the fact that this agree­ment with such a promising Italian bio­tech, as Genenta, allows MolMed to play an active role in promoting the strengthening and growth of the bio­tech sector in Italy”.

“The aim of Genenta Science is to rapidly translate the pre­clin­i­cal results of its gene ther­apy ap­proach against tumors to the patients, while ensuring scientific excellence and patients’ safety.” Pierluigi Paracchi, Chairman and CEO of Genenta Science said, “The agree­ment signed with MolMed allows us to effectively reach this pur­pose.”

About Multiple Myeloma

Multiple myeloma is a bone marrow cancer consisting in malignant plasma cells with a damaged DNA. Normally, plasma cells produce anti­bodies for the host immune response. In case of Multiple Myeloma, the malignant plasma cells accumulate in the bone marrow crowding out healthy blood cells, secreting inflam­matory cytokines, thus causing anemia and immune suppression. Moreover, an ab­nor­mal synthesis of osteoclasts, cells deputed to the bone resorption, determines bone fragility and bone fractures.

About Genenta Science

Genenta Science develops a gene transfer strategy into au­tol­o­gous hematopoietic stem cells (HSCs) to target interferon-α ex­pres­sion to tumor-infiltrating monocytes/macrophages. An HIV-derived and genetically disabled viral vector - Lentivirus - delivers the gene into the HSCs. Interferon is a protein usually produced by the body in response to in­fec­tions that also exhibits a pleiotropic anti-tumor activity. However, the clin­i­cal use of interferon-α as a drug has been limited by its high toxicity. The inno­va­tive ther­apy of Genenta Science, by combining transcriptional and microRNA-mediated control, enables tumor-infiltrating monocytes/​macro­phages to selectively express interferon-α limited to the tumor area, thus reducing its toxicity.

The founders of the com­pany are:

• Pierluigi Paracchi - former investor and board member at Ethical Oncology Science (EOS), an Italian start up acquired by Clovis Oncology (Nasdaq: CLVS) for USD 420 million
• San Raffaele Hospital - the leading Italian research institute
• Luigi Naldini - Director of the San Raffaele-Telethon Institute for Gene Therapy (TIGET) and of the Division of Regenerative Medicine, Stem Cells and Gene Therapy at the San Raffaele Hospital, Professor of Histology and Gene and Cell Therapy, at the San Raffaele University
• Bernhard Gentner - Haematologist and Physician Scientist at the San Raffaele Hospital and TIGET In March 2015, Genenta Science banked a Euro 10 million (USD 11 million) Series A round with Banca Esperia as financial advisor.

About MolMed

MolMed S.p.A. is a medical bio­technology com­pany focused on research, devel­op­ment and clin­i­cal valida­tion of novel anticancer ther­a­pies. MolMed’s pipe­line in­cludes anti-tumour thera­peutics in clin­i­cal and pre­clin­i­cal devel­op­ment: Zalmoxis® (TK) is a cell-based ther­apy enabling bone marrow trans­plants from partially compatible donors, in absence of post-transplant immune-suppression, cur­rently in Phase III in high-risk acute leukaemia and under evaluation by EMA for a Conditional Marketing Authorization; NGR-hTNF is a novel thera­peutic agent for solid tumours which displays antitumor activity through its specific binding to blood vessels feeding the tumour mass, cur­rently in­ves­ti­gated in a broad clin­i­cal pro­gramme; CAR-CD44v6, an immuno-gene ther­apy project poten­tially effective for many haematological malig­nan­cies and several epithelial tumours, cur­rently in pre­clin­i­cal devel­op­ment. MolMed also offers top-level expertise in cell and gene ther­apy to third parties to develop, conduct and val­i­date projects from pre­clin­i­cal to Phase III trials, in­­clud­ing scale-up and cGMP pro­duc­tion of clin­i­cal-grade viral vectors, and manu­fac­tur­ing of patient-specific genetically engi­neered cells. MolMed has its headquartered at the San Raffaele Biotechnology Department (DIBIT) in Milan, Italy, and a local unit at OpenZone, in Bresso (Milan). MolMed is listed on the main market (MTA) of the Milan stock exchange man­aged by Borsa Italiana (ticker Reuters: MLMD.MI).

Disclaimer

This press release may con­tain certain forward-looking state­ments. Although the Company believes its ex­pectations are based on reason­able assump­tions, these forward-looking state­ments are subject to numer­ous risks and un­cer­tain­ties, in­­clud­ing scientific, business, economic and financial factors, which could cause actual results to differ materially from those antic­i­pated in the forward-looking state­ments. The com­pany assumes no responsibility to update forward-looking state­ments or adapt them to future events or develop­ments. This document does not constitute an offer or invitation to subscribe or purchase any securities of MolMed S.p.A.

Source: MolMed.